What’s the Deal With Segmented Cleanrooms?

What’s the Deal With Segmented Cleanrooms?

by | Jul 23, 2020 | Cleanroom Terminology, Filtration

An important part of cleanroom design is the choosing the best layout to suit your unique application. If your cleanroom has the challenge of needing to meet changing requirements or different levels of cleanliness, air changes, or pressure for different stages of work or to contain hazardous substances, it can be complicated to fit all of your cleanroom needs in one design. 

The solution to this problem is to segment your cleanroom design. Segmented cleanrooms are commonly used in medical applications that require separate spaces for different products or processes to ensure the safety of employees and their work.  Let’s explore segmented cleanrooms and their uses, and how their attributes can go beyond necessity in medical cleanrooms.

 

What Are Segmented Cleanrooms?

Segmented cleanrooms embrace different requirements and cleanroom classifications within a single cleanroom design. To do this, separate spaces are created within the cleanroom and modified to match the necessary requirements. Depending on the needs of the facility, this could mean a cascading pressure system utilizing a negative pressure room and higher pressure ante room; separate areas that meet different classifications, such as for manufacturing vs. packaging, treatment vs. isolation and quarantine, etc.; or any other separate-but-linked purposes your application requires.

Even when segmenting your cleanroom design isn’t required by your industry-specific standards or cleanroom classification, segmentation can offer added benefits like energy efficiency and cost savings. Rather than running the entire cleanroom at the lowest possible classification, a segmented cleanroom makes use of its systems where they’re most needed. This saves energy from powering FFUs and the cleanroom HVAC system, and lessens the strain on expensive HEPA filters. Also, there may be areas in the cleanroom where specialized products, like ESD-safe or classification-compliant materials, can be limited. By restricting use of those extra materials and energy costs to the segment where they’re being used, you’ll save money in your cleanroom design, build, and daily operational costs.

 

What Medical Applications Benefit from Segmented Cleanrooms?

Segmented cleanrooms are useful in medical applications where different requirements are necessary, particularly in medical device cleanrooms, pharmaceutical cleanrooms, and medical research cleanrooms.

Medical Device Cleanrooms

Medical device cleanrooms are governed by different requirements depending on the stage of production;  for example, between manufacturing and packaging. Most medical device manufacturing cleanrooms are required to comply with ISO 14644-1 Class 5-7, while medical device packaging is regulated by Class 7-8 standards. Also, while both phases are confronted with risks due to electrostatic discharge, it is most important to control static in the packaging phase, requiring more safeguards to dispel or conduct charges away from devices using ESD-safe equipment and materials. 

A segmented medical device cleanroom design could accommodate all of these requirements, by separating classifications within the same facility. Rather than running the entire space at the lowest possible classification, a segmented cleanroom would save significant energy costs, and be able to more efficiently prioritize operations according to each phase of medical device assembly.

Pharmaceutical Cleanrooms

Many pharmaceutical cleanrooms are designed using cascading pressure rooms with different pressure levels. In this system, each segment has a higher or lower pressure and a specific use to help protect contaminants from leaving one space and transferring to another where they could reduce the effectiveness of compounds, nullify test results, or even endanger human or animal life.

For example, the compounding area in a pharmaceutical cleanroom has different classification requirements and even a different pressure than the ante room attached to it. The purpose of the ante room is to allow the pressure difference to exist, and create a step down for employees to prepare before entering or after exiting the stringent segment. Segmented cleanrooms allow a single pharmaceutical cleanroom to house separate classifications in order to work with hazardous compounds safely and efficiently.

Medical Research Cleanrooms

Medical research cleanrooms may require an adjacent space for biosafe procedures or to house a negative pressure room. If the work involves sensitive or hazardous substances, a more rigorous classification and pressure will be required to isolate the work from external contamination or restrict contaminants from exiting the cleanroom. Segmented cleanrooms are used to allow these processes to occur within the same facility. An intuitive cleanroom design helps researchers focus on their work and feel safe within their environment. 

Interested in a unique cleanroom layout for your application? Get in touch with Angstrom Technology! Whether you want to create a segmented pharmaceutical cleanroom or upgrade your cleanroom classification, our experts can help you design, build, and install the ideal cleanroom for you. Reach out to us online today for a free quote.

3 Common Types of Cleanrooms

3 Common Types of Cleanrooms

by | Jul 16, 2020 | Cleanrooms

If you know you need a controlled space to operate your business, a cleanroom is designed to help you achieve a completely clean environment to work, while managing environmental factors like temperature, humidity, static, and pressure. Whether you’re manufacturing, developing, inventing, testing, or packaging, various cleanroom types will offer you different features. Some might be better suited for certain cleanroom classifications or offer special features or more compatibility with your unique application. Let’s take a look at three common types of cleanrooms: HardWall, SoftWall, RigidWall cleanrooms.

 

HardWall Cleanrooms

 

For cleanrooms with rigorous classification standards, HardWall cleanrooms are designed to comply with any cleanroom classifications, even the most stringent (ISO Class 1).

HardWall cleanrooms can be freestanding or incorporated into an existing building. Made using a coated aluminum frame with a prefabricated panel, HardWall modular cleanroom panels are designed to achieve a high level of control over static, pressure, humidity, and contamination.

A great advantage of HardWall cleanrooms is that they can be installed in an existing structure around mounted equipment, using light from the building’s windows and connecting to the existing HVAC system. This cleanroom type also offers extreme environmental control beyond particle count and air changes. In addition to management of temperature, static, and humidity, HardWall cleanrooms can be pressurized if your classification requires extra contaminant protection. 

HardWall cleanrooms can comply with any industry specific requirements and are well suited for all cleanroom applications such as medical cleanrooms —  including research and pharmaceuticals —  aerospace cleanrooms, and even sensitive electronics manufacturing or semiconductor cleanrooms. HardWall cleanrooms can be easily modified or reconfigured by adding or removing modular panels, and are durable enough to be reused, relocated, and repurposed while maintaining their quality.

 

SoftWall Cleanrooms

 

SoftWall cleanrooms are a minimalist, lightweight cleanroom type that can accommodate most cleanroom classification standards. SoftWall cleanrooms can fit in almost any space and are fully customizable with a wide variety of filtration options, door types, and other modifications. 

Featuring an aluminum alloy frame and clear or opaque vinyl curtains around the perimeter, SoftWall cleanrooms are designed to be more compact, so they can work almost anywhere in your facility — even within another cleanroom. Of course, if you’re looking to expand, custom sizes are available. Curtains are made from anti-static or conductive PVC or polyethylene. 40 mil clear is the standard option, but frosted or clear anti-static vinyl are also available as well, in a range of colors for UV absorption. During installation, wiring is installed on-site, with optional pre-assembled wiring harnesses. You can also choose to install standard fan filter units and a control panel for FFUs, lighting, and other wiring. 

SoftWall Cleanrooms are able to reach most cleanroom classifications, and are ideally suited for ISO Classes 4-8.

If you’re looking for an affordable cleanroom option that’s easy to assemble and maintain, a SoftWall cleanroom would be perfectly suited for your application. SoftWall cleanrooms have the advantage of being an affordable modular option that don’t sacrifice their high performance capacity. Their extremely flexible design makes them a great choice for applications that need room to grow, including plastics manufacturing, automotive cleanrooms, growrooms, and some medical cleanroom applications.

 

RigidWall Cleanrooms

 

RigidWall cleanrooms can also provide a suitable environment for applications with less stringent classification requirements, with some flexibility that allows you to make changes as necessary to the layout and design of your cleanroom. RigidWall panels have a durability comparable to HardWalls, with full visibility floor to ceiling. They are best used for cleanrooms with classifications ISO Class 5-8.

With a choice of acrylic, static dissipative PVC, or polycarbonate wall panels, a RigidWall cleanroom will house your operations in a transparent, attractive style. Unlike the SoftWall curtain or the utilitarian HardWall panels, RigidWall panels are sleek and minimalist. Flat, clear panels allow easier monitoring of the cleanrooms while also creating an attractive feature for the space, making them a perfect frame to show off your work to investors.

An advantage of RigidWall cleanrooms is that they are easy to maintain. Although they aren’t as flexible as SoftWall panels, RigidWalls can be modified with some effort, or even stored if you need to free space for something else. RigidWall panels can be customized in size with heights up to 7-14 feet, and come pre-wired with outlets and switches to control lighting, fans, and equipment. Panels are suspended from a strong ceiling grid which, fully-secured, means the panels will maintain their shape and integrity over time.

RigidWall cleanrooms make a high-performance choice for a number of applications such as automotive cleanrooms, aerospace cleanrooms, and some medical device packaging and plastics cleanrooms.

All cleanroom types can be fully customized or modified to your unique application. Whether you need a highly controlled environment to meet stringent cleanroom classification requirements or an affordable option to allow your operations to grow, a HardWall, SoftWall, or RigidWall cleanroom would be a great choice for your facility.

Still not sure which cleanroom type is best for your application? Talk to the experts at Angstrom Technology. No matter what type of cleanroom you need, we can help you design and install it. To help you decide which cleanroom type is best for you, give us a call!

HVAC System Requirements for Aerospace Cleanrooms

HVAC System Requirements for Aerospace Cleanrooms

by | Jul 9, 2020 | Aerospace Cleanrooms

Aerospace cleanrooms require a high level of control. They can range from an ISO 14644-1 Class 5-7, which have vastly different requirements. At a minimum ISO Class 7, the cleanroom will require about 60-90 air changes per hour and need to filter out a range of particle sizes, including all but 352,000 of microns 0.5 or larger per cubic meter. The cleanroom’s filtration system, airflow pattern, and ceiling fan coverage all work together to reach these stringent cleanroom classifications. In addition to these components, there’s another system that is integral to maintaining control and supporting other factors of cleanroom design: the cleanroom HVAC system.

The aerospace cleanroom HVAC system effectively controls temperature, humidity, and ventilation within the space. It helps make sure all processes run smoothly and helps keep the cleanroom clean and efficient. Let’s explore the basic cleanroom HVAC requirements for environmental control of temperature, humidity, and ventilation, and how these three factors can play an important role in aerospace cleanroom operations.

 

Aerospace Cleanroom HVAC Temperature

A cleanroom HVAC system is crucial for controlling temperature within your aerospace cleanroom. It’s important to manage temperature, not only to keep employees comfortable but to maintain a stable environment. Some processes within aerospace cleanrooms generate significant heat and need to be balanced with proper cooling to prevent both staff and equipment from overheating. 

Temperature fluctuations could affect cleanroom operations if some equipment, parts, or materials are temperature sensitive. Some sensors or electronics will not function effectively in an unstable environment. Also, expanding and contracting as a response to temperature changes could affect manufacturing equipment or products and lead to failure.

The cleanroom HVAC system can fine-tune temperature to optimal levels and make adjustments as needed depending on operating needs and project requirements. NASA recommends an optimal temperature of 67-77°F in aerospace cleanrooms ISO Class 5-8. For less restricted aerospace cleanroom applications, higher temperatures up to 80°F are allowed.

 

Aerospace Cleanroom HVAC Humidity

Humidity can affect aerospace cleanroom operations from minor to major ways, from changes to paint drying time or consistency to the disruption of fine electrical parts or sensors. At a minimum, humidity in aerospace cleanrooms should be controlled to prevent condensation on surfaces, which could not only affect the performance of hardware within the cleanroom but also could attract surface particulates and contaminate products.

The HVAC system is responsible for regulating appropriate humidity levels within the controlled cleanroom environment. Humidity in an aerospace cleanroom should be 30% at minimum, and not exceeding a maximum of 50%.

 

Aerospace Cleanroom HVAC Ventilation

Proper ventilation is key to meeting stringent air change or air velocity requirements in an aerospace cleanroom. Optimal and consistent ventilation is essential for supplying the cleanroom with clean air, and is the foundation for all other systems to function effectively. Proper ventilation powers the cleanroom airflow pattern, limits airborne particles with the support of filters, and prevents surface particles from settling and contaminating the cleanroom environment.  

Airflow also creates a pressure differential. Positive pressure in aerospace cleanrooms helps prevent contaminants from entering the controlled environment, especially through small spaces in the structure around doorways, between panels, or other weak points. To achieve positive pressure, the cleanroom HVAC system will push more air into the cleanroom than is allowed out. Only a slight degree of pressurization is needed to achieve positive results.

 

Choosing the Right Cleanroom HVAC

Depending on your application, your aerospace cleanroom will have to meet a classification as well as specific industry requirements. These also stipulate control over environmental factors that could interfere with cleanroom operations. In addition to proper filtration and ceiling coverage of FFUs, your cleanroom HVAC system is important to maintaining a controlled environment. Establishing complete control over environmental factors like temperature, humidity, and ventilation, your cleanroom’s HVAC is a vital part to achieving project success. 

Depending on your application’s unique needs and cleanroom classification, a more powerful HVAC system might be required. Your capabilities within your cleanroom are determined by your collective systems’ ability to manage the environment, effectively change the air, and consistently remove particles to keep the space clean and contaminant-free. 

Is your existing cleanroom HVAC system powerful and efficient enough to meet your needs? Whether you’re shopping for a new HVAC or looking to update your existing one, Angstrom Technology can help! We understand aerospace cleanroom HVAC requirements and can help you get the most out of your system for full temperature, humidity, and filtration control. To have our experts assess your HVAC or go over your requirements for a new system, give us a call or reach out online.

3 Medical Industries that Use Negative Air Pressure Cleanrooms

3 Medical Industries that Use Negative Air Pressure Cleanrooms

by | Jul 2, 2020 | Medical Laboratory Cleanrooms

It’s a well-known natural process for air to flow from high to low pressure. Examples of this are found around us every day. Wind and weather are formed from the uneven heating of the earth’s surface which generates pockets of high and low pressure air. If you’ve ever witnessed the sudden closing of a door as air is sucked out of a room where no breeze was felt, what you experienced was the high pressure air moving to a low pressure area to achieve stasis. 

High and low pressure, or positive and negative pressure, can be used as a tool in cleanroom environments to protect against entering contaminants (in positive pressure cleanrooms) or contaminant leakage (in negative pressure cleanrooms). We’re going to focus on negative pressure cleanrooms, how they work, and how they are especially important in some medical cleanroom applications. 

 

What are Negative Air Pressure Cleanrooms?

 

In a cleanroom, pressurization can be achieved using airflow and air direction. Negative pressure cleanrooms exhaust more air than they supply to create a lower pressure than is found in the surrounding rooms. Negative pressure in cleanrooms is useful because it prevents any contaminants or hazardous substances inside the cleanroom from leaking out where they could contaminate adjacent rooms or endanger employees.

Negative pressure is used in sensitive applications where processes or substances within the cleanroom could be hazardous to work or health outside. Negative pressure is a simple way to further limit the possible escape of harmful particles, fumes, or substances, when used effectively with proper filtration and adequate ventilation.

How Negative Pressure Cleanrooms Work

 

To achieve negative air pressure, external exhausts pull air from the cleanroom at a faster rate than air is introduced over a span of time. The resulting negative pressure means air will want to flow into the cleanroom to fill the low pressure area, effectively stopping contaminants from going against that natural movement in order to escape the cleanroom.

In order for the negative pressure cleanroom to work, adjacent spaces must be maintained at a higher pressure than that of the cleanroom. A slight difference in pressure will prove effective at limiting contaminants, but the greater the pressure differential, the stronger the force of air that wants to move to achieve equilibrium, and thus the greater the resistance for contaminants to move the opposite direction. However, it is possible to have pressure that is too negative, as this could force contaminants into the cleanroom, where they could be detrimental in some applications.

Some cleanrooms only require a slightly negative pressure in order to contain aerosols, while others require a higher pressure difference to aid in containing hazardous liquids or gases from transferring in pass-throughs or other access points. Depending on your application, you may choose a higher pressure differential in order to limit the possible escape of hazardous liquids or toxic fumes. In any case, having a pressure monitoring system is important to ensuring balance and consistency within your cleanroom. If you’re exploring negative pressure cleanroom design, it’s a good idea to build in a monitoring system so you can always check and alter pressure as needed.

Determining Where to Use Negative Pressure in Cleanrooms

 

Negative pressure can be used in a small area, as the total cleanroom pressure, or in part of the cleanroom design such as in a passthrough, workstation, or storage cabinet. An external exhaust removes air and airborne contaminants, odors, or fumes, and prevents hazardous, toxic substances from escaping the negatively pressurized space. 

Some cleanrooms require an enclosed space within the cleanroom to be at a different pressure than surrounding spaces. These are known as negative pressure rooms and are commonly found in pharmaceutical or medical research cleanrooms working with hazardous compounds or infectious particles. Negative pressure rooms are an example of a segmented cleanroom, where other segments may meet different classification requirements or have different needs for pressure, cleanliness, or operating procedures.

Medical Industries and Negative Air Pressure Cleanrooms

 

Negative pressure cleanrooms are particularly useful in medical applications where the work involves hazardous compounds, toxic fumes, or infectious substances. A few examples of medical industries that use negative pressure cleanrooms are hospitals, medical research laboratories, and the pharmaceutical industry.

Hospital Cleanrooms

 

Hospitals use negative pressure cleanrooms to contain airborne contagions, pathogens, and viruses.

Whether for research, treatment, preventative isolation or quarantine, negative pressure helps seal in dangerous contaminants to keep hospital staff and patients safe. Hospital cleanroom applications that work with hazardous drugs or infectious diseases are often required to use negative pressure when handling products and treating patients. 

Medical Research Cleanroom

 

Medical research, especially that which involves hazardous substances, aerosol contaminants, or toxic waste, is generally done within the confines and protection of a biosafe cleanroom. Negative pressure is used to prevent any harmful particles from escaping the cleanroom where they could contaminate other spaces or endanger human or animal lives. Negative pressure cleanrooms protect researchers by containing hazardous materials or substances within the cleanroom, where staff is prepared with proper gowning and protective equipment. 

Pharmaceutical Cleanrooms

 

Pharmaceutical cleanrooms, particularly those that must comply with USP 800 standards for sterile and non sterile compounding of hazardous materials often require negative pressure to operate safely. Negative pressure cleanrooms allow for safer handling of hazardous drugs, presenting fewer risks to employees and consumers. USP 800 pharmaceutical cleanrooms require a dedicated water channel gauge to monitor pressurization, ensuring that the differential is high enough to be effective, but not too high where it could reduce efficiency and potentially bring contamination into critical parts of the cleanroom. 

Negative pressure cleanrooms are helpful in cleanrooms where the emphasis is on containing the work, product, or processes within the cleanroom. Although they are particularly useful in many medical cleanroom applications, some negative pressure cleanrooms can be found in other industries where hazardous materials need to be controlled. 

Need a negative pressure cleanroom for your sensitive application? At Angstrom Technology, we have the tools and expertise to design the cleanroom that best fits your application and your budget. For a free quote, reach out to our team.